FDA 510(k) Application Details - K070060

Device Classification Name Blood Pressure Cuff

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510(K) Number K070060
Device Name Blood Pressure Cuff
Applicant WELCH ALLYN, INC.
4341 STATE STREET ROAD
PO BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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Contact JOHN SAWYER
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 01/05/2007
Decision Date 12/18/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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